MAUDE Adverse Event Report: Nalu Medical, Inc Nalu Neurostimulation System; Peripheral Nerve Stimulator

Model Number	72013
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The nalu sales representative (rep) reported that when the physician placed an eic on the lead, that all contacts showed bad impedances.Troubleshooting was done and the lead continued to show bad impedances.The clincial programmer app was restarted and there were now only a couple of contacts that were bad and programing was attempted.The patient was not feeling the stimulation, and the physician repositioned the lead.The physician removed the lead and put it in the other port, and as he did, the top of the esc snapped in two, and a new one was used.The case continued with new lead and a new eic and the case was completed without issue.
Additional Manufacturer Narrative
After conducting a post-acquisition, retrospective review of nalu peripheral nerve stimulation complaint records, boston scientific determined that this event meets mdr reporting criteria.The following mdr information is being submitted as part of capa investigation pcar42.All malfunctioning leads were discarded during the procedure and thus are not available for inspection by the firm.There were multiple people handling the devices during the procedure and reports of multiple attempts at connecting and reconnecting the components.Therefore, the root cause of the reported event could not be determined.

• Brand Name: Nalu Neurostimulation System
• Common Device Name: Peripheral Nerve Stimulator
• Manufacturer (Section D): Nalu Medical, Inc; 2320 faraday ave; suite 100; carlsbad CA 92008 -724
• Manufacturer (Section G): Nalu Medical, Inc; 2320 faraday ave; suite 100; carlsbad CA 92008 -724
• Manufacturer Contact: rebecca hess ; 2320 faraday ave; suite 100; carlsbad, CA 92008--724
• MDR Report Key: 50867030
• Report Number: 3015425075-2026-00666
• Device Sequence Number: 18447514
• Product Code: GZF
• UDI-Device Identifier: 00812537036175
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/15/2024
• Device Model Number: 72013
• Device Lot Number: PG636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown